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Results confirm findings of earlier study
Montreal, Canada | June 18, 2008 | Theratechnologies (TSX:TH) today announced positive 26-week results for its confirmatory Phase 3 clinical trial, evaluating the efficacy of the Company's lead compound, tesamorelin, in patients with HIV-associated lipodystrophy. As described in the protocol and agreed to by the Food and Drug Administration (FDA) through the Special Protocol Assessment (SPA) process, the study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. The study met its primary endpoint as well as important secondary endpoints confirming the positive results obtained in the Company's initial Phase 3 study.
"In this second Phase 3 trial, tesamorelin is again proving to be efficacious at reducing VAT, without reducing subcutaneous adipose tissue (SAT), while being well tolerated in patients," commented Mr. Yves Rosconi, President and Chief Executive Officer of Theratechnologies. "These confirmatory data are critical to the New Drug Application (NDA) submission that is in preparation to obtain market approval for tesamorelin," concluded Mr. Rosconi.
"Once again, we have met key clinical endpoints, this time treating European as well as North American HIV positive patients," commented Dr. Christian Marsolais, Vice President, Clinical Research of Theratechnologies. "These data add further strength to tesamorelin's product profile for a disease with no approved treatment available. We thank all our employees, collaborators, principal investigators and, particularly, the patients for their participation in this trial," added Dr. Marsolais.
Efficacy Results
The primary endpoint for the study was VAT reduction while the four secondary endpoints were positive changes in body image (belly appearance distress), triglyceride levels, the total cholesterol to HDL ratio and IGF-1 levels.
Patients treated with tesamorelin for 26 weeks achieved an average of 11% decrease in VAT versus baseline (p<0.001) and 10% versus placebo (p < 0.001). In absolute terms, the average VAT reduction was -20.6 square centimetres (p<0.001 versus placebo). Body fat was preferentially lost in the visceral cavity, with no significant changes in SAT.
This study also demonstrated that treated patients significantly improved their belly appearance distress compared to the placebo group (p= 0.02). This is considered to be an important endpoint because of its implications for patient adherence to HIV regimens.
With respect to lipid profiles, a trend for improvement in triglyceride levels was recorded for the treated group versus placebo (p=0.08) and was significantly different versus baseline (p=0.006). There was no significant impact on the total cholesterol to HDL cholesterol ratio.
IGF-1 mean levels were within physiological range and increased by 73% compared to placebo (p<0.001).
Safety
There were no clinically significant differences between the tesamorelin-treated group and placebo in glycemic control. Adverse events with an incidence of more than 10% were: injection site redness (erythema: 14.1% versus 4.8% for placebo); injection site itchiness (pruritis: 10.4% versus 1.6% for placebo); and joint pain (arthralgia: 12.2% versus 11.1% for placebo). The drop out rate for the patients treated with tesamorelin was 25% compared to 27% for the placebo group.
ENDO 2008
Theratechnologies also presented data yesterday from its first 52-week Phase 3 study testing tesamorelin in HIV-associated lipodystrophy at ENDO, the 90th annual meeting of the Endocrine Society. The presentation reviewed previously disclosed glucose tolerance and lipid data and was made by Dr. Donald Kotler, an investigator for the tesamorelin trial in the United States who is also Chief, Division of Gastroenterology and Liver Disease, St. Luke's-Roosevelt Hospital Center and Columbia University College of Physicians and Surgeons, in New York.
HIV-Associated Lipodystrophy
Caused by several factors including the antiviral drug regimen and the virus itself, HIV-associated lipodystrophy is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal visceral fat accumulation and loss of subcutaneous fat in the limbs and in the face. Excess VAT and its concomitant metabolic profile have recently been shown to be a risk factor for cardiovascular diseases in HIV patients. There is currently no approved treatment available for HIV-associated lipodystrophy, a serious condition that can stigmatize patients and discourage HIV treatment adherence.
About Theratechnologies
Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company that discovers innovative drug candidates in order to develop them and bring them to market. The Company targets unmet medical needs in financially attractive specialty markets. Its most advanced program is tesamorelin, now in a confirmatory Phase 3 clinical trial for a serious metabolic disorder known as HIV-associated lipodystrophy. The Company also has other projects at earlier stages of development.
SOURCE: Theratechnologies |
